BELLATEKRecalls & reported problems across all models
ZimVie US Corp LLC · 17 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 41
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 1
We found 17 models of BELLATEK by ZimVie US Corp LLC in the FDA's device registry (GUDID). Together they are named in 41 adverse event reports in the FDA's MAUDE database, received between Mar 31, 2020 and Sep 30, 2026 — classified as 2 injuries, 39 malfunctions.
The most frequently reported specific device problem is “Fracture” (31 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
BELLATEK recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 31, 2020Terminated
Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
Z-0074-2021 · Root cause: Device Design · Recall details · FDA record ↗
Most reported BELLATEK problems
Device problems
- Fracture31
- Unintended Movement8
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions36
- Unspecified Infection2
- Difficulty Chewing1
- Insufficient Information1
- No Code Available1
- No Information1
BELLATEK models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BELLATEK® EDAT4ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall0 reports
- BellaTek MHLASCAbutment, Implant, Dental, Endosseous8 reports
- BELLATEK® CSHY04ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS6 reports
- BELLATEK® CSHY05ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS5 reports
- BELLATEK® TSVLDAZR3ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS5 reports
- BELLATEK® CSHY06ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS3 reports
- BELLATEK® TSVLDAT4ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS3 reports
- BELLATEK® TSVIOSEDAZR3ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 reports
- BELLATEK® CSD04ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
- BELLATEK® CSH04ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
- BELLATEK® CSHY08ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
- BELLATEK® EDAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
- BELLATEK® LDAT4ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
- BELLATEK® TSVLDAT3ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
- BELLATEK® IF3121ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
- BellaTek TE351Abutment, Implant, Dental, Endosseous1 report
- BellaTek TF4121Abutment, Implant, Dental, Endosseous1 report
Recent BELLATEK adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fracture
It was reported that patient presented with implant crown in hand, reports it came out two days ago. Exam revealed fractured hex off of Bellatek Custom abutment and fractured prosthetic screw. Remaining portion of screw in pt¿s #30 site along with fractured portion of custom abutment hex. Remaining portion of fractured device removed under local anesthesia and tissue punch to remove gingival overgrowth. Placed TEEHA465 encode for healing. Patientt unable to fully masticate on a right side. Abutment placed on (b)(6) 2024 and removed on (b)(6) 2026.
Patient problems: Difficulty Chewing
MAUDE report 50948112 ↗MalfunctionMar 3, 2026Fracture
IT WAS REPORTED THAT THE HEX PORTION OF THE ABUTMENT BROKE OFF IN THE PATIENT'S MOUTH. THE LAB IS UNSURE IF THEY WILL REMAKE IN TI.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24496940 ↗MalfunctionMar 3, 2026Unintended Movement
IT WAS REPORTED THAT THE ABUTMENT/CROWN LOOSENED AFTER BEING PLACED. THE ABUTMENT/CROWN WAS SWALLOWED BY THE PATIENT. A NEW SCAN WAS SENT TO REMAKE THE ABUTMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24496649 ↗MalfunctionOct 15, 2025Fracture; Fracture
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23302034 ↗MalfunctionJun 16, 2025Fracture; Fracture
IT WAS REPORTED THAT THE BAR BROKE IN THE PATIENT¿S MOUTH ON THE CYLINDER IN THE TOOTH #29/30 AREA. THE PATIENT WILL BE WEARING THE BAR AS A TEMPORARY UNTIL THE NEW BAR IS COMPLETED AND INSERTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22214332 ↗MalfunctionApr 7, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21786978 ↗MalfunctionMar 18, 2025Fracture; Fracture
IT WAS REPORTED THAT THE BAR BROKE IN HALF IN THE PATIENT¿S MOUTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21634907 ↗MalfunctionFeb 18, 2025Fracture; Fracture
IT WAS REPORTED THAT THE BAR FRACTURED IN PATIENT¿S MOUTH BETWEEN TOOTH NUMBERS 20 AND 21. BAR WILL BE REMADE BEETWEN TOOTH-20,22,24,25,28.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21397862 ↗MalfunctionJan 30, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21278048 ↗MalfunctionJan 30, 2025Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21277947 ↗MalfunctionJan 6, 2025Fracture; Fracture
IT WAS REPORTED THAT THE FREE-END SADDLE OF THE BAR BROKE OFF AT SITE # 28-29 AREA. LAB WILL BE SENDING BACK AS WELL AS HAVING BAR REMADE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21079906 ↗MalfunctionJan 6, 2025Fracture; Fracture
IT WAS REPORTED THAT THE FREE-END SADDLE OF THE BAR BROKE OFF AT SITE # 28-29 AREA. LAB PREVIOUSLY REPAIRED THE WEEK OF DECEMBER 2ND. BAR BROKE AGAIN. LAB WILL BE SENDING BACK AS WELL AS HAVING BAR REMADE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21079796 ↗MalfunctionJan 6, 2025Fracture; Fracture
IT WAS REPORTED THAT A SCREW FRACTURED IN THE PATIENT'S MOUTH AT TOOTH #19. REQUESTED SCREW REMOVAL TOOLS TO RETRIEVE THE BROKEN PORTION FROM THE IMPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21078842 ↗MalfunctionDec 26, 2024Fracture; Fracture
IT WAS REPORTED THAT THE BAR BROKE IN PATIENT'S MOUTH. WILL BE RETURNING THE BROKEN ONE AND REMAKING A NEW BAR. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21021203 ↗MalfunctionOct 11, 2024Fracture; Fracture
IT WAS REPORTED THAT THE ABUTMENT FRACTURED. NO FURTHER INFORMATION WAS PROVIDED. TOOTH SITE # 12.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20434060 ↗
Other ZimVie US Corp LLC products
- Tapered Screw-Vent131 models · 13,236 reports · 4 recalls
- OSSEOTITE CERTAIN74 models · 1,891 reports · 1 recall
- TSX Implants28 models · 1,279 reports
- OSSEOTITE73 models · 894 reports
- 3i T3 DCD73 models · 789 reports
- OSSEOTITE CERTAIN PREVAIL15 models · 785 reports
- CERTAIN BELLATEK12 models · 9 reports · 10 recalls
- Eztetic15 models · 382 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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